Medicament delivery device

ABSTRACT

A medicament delivery device is presented having a housing configured to receive a medicament container having a delivery member and a shield, a protective cap, and wherein the protective cap comprises connecting means for connecting to the shield of the medicament container such that removal of the protective cap from the housing causes removal of the shield from the medicament container. The delivery device is characterised in that a protective cap assembly has a first disconnecting means configured to interact with corresponding second disconnecting means of the housing and of the protective cap such that activation of the first disconnecting means of the protective cap assembly causes the displacement of the protective cap relative to the housing.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a U.S. National Phase Application pursuant to35 U.S.C. §371 of International Application No. PCT/EP2013/054654 filedMar. 7, 2013, which claims priority to Swedish Patent Application No.1250238-1 filed Mar. 14, 2012, which is claims priority to U.S.Provisional Patent Application No. 61/610,567, filed Mar. 14, 2012. Thepresent application also claims priority to Swedish Patent ApplicationNo. 1251235-6 filed Nov. 1, 2012 which claims priority to U.S.Provisional Patent Application No. 61/721,049, filed Nov. 1, 2012. Theentire disclosure contents of these applications are herewithincorporated by reference into the present application.

TECHNICAL AREA

The present invention relates to a medicament delivery device arrangedwith a protective cap assembly designed for removal of needle shieldsoff medicament containers of the medicament delivery device.

BACKGROUND

There are many medicament delivery devices on the market that have beendeveloped for self administration of medicament, where one large groupis medicament injection devices. Many of these injection devices havebeen provided with removable needle cover assemblies where the corecover may be a so called Rigid Needle Cover or Rigid Needle Shield (RNS)or a so called Flexible Needle Cover or Flexible Needle Shield (FNS).

These RNS/FNS's are arranged to protect the injection needle before usein order to keep the needle sterile and also protect from unintentionalneedle sticks. Many of these RNS/FNS's are pushed onto the neck portionof a medicament container, such as a syringe, where the RNS/FNS areprovided with an inner cap in contact with the surface of the syringe.The inner cap is preferably of a resilient material, normally rubberthat ensures a tight grip and a good seal between the cap and thesyringe. However this tight grip entail problem in that it is difficultto remove the RNS/FNS from the syringe in order to perform an injection.

Therefore a number of RNS/FNS removal devices have been developed, whichare intended to aid the user in removing the RNS. DocumentsWO2007/047200, WO 2006/106290 and WO 2005/115508 disclose differentsolutions to this problem. However, they all include a function wherethe whole assembly including the RNS and its resilient inner cap, aretwisted or rotated manually. This a major drawback since this twistingaction if the inner cap very easily causes damage to the injectionneedles, which usually are thin and easily bendable such that when theRNS is removed, the needle has become so damaged it cannot be used forthe injection.

Also, all these solutions require manual action by gripping the shieldremover mechanism and performing a number of manual operations such astwisting and pulling and combinations thereof. This is a drawback forall persons with reduced dexterity in their hands as well as reducedmotion control. Further, all these solutions require change of grip ofthe medicament delivery device after removal of the RNS/FNS. This mayalso be a drawback in that the injection needle now is exposed when theuser is to change grip for the subsequent penetration and injection. Notonly may the thin needle be damaged during the process, but the user orother persons in the vicinity may be damaged by the exposed needle.

Document WO 2009/019440 discloses an injection device comprising a capthat in order to be removed is rotated turns about the longitudinalaxis. During rotation, the needle shield retainer does not rotaterelative to a discharge nozzle and the rotational movement of the caprelative to the housing is converted into linear movement of the needleshield retainer away from the exit aperture in the axial directionachieved through engagement of the screw threads so the needle shield ispulled away from the discharge nozzle through the exit aperture into thecentral boss. After rotation, the user finally pulls the cap away fromthe housing, the needle shield and the discharge nozzle are not engagedwith each other and the cap becomes completely detached from theinjection device.

The device according to '440 does not thus twist or rotate the needleshield but a rotational interaction with threaded components causes alinear movement of the needle shield retainer from the exit aperture ofthe medicament delivery device. However, the solution is complexregarding the number of components required, and still a manual grippingaction as described above is required. Again, the user has to changegrip after removal of the needle shield with the addressed risks thatthis may induce.

There is thus a need for solutions that simplify the removal of needleshields from medicament delivery devices, reducing the risk of damagingthe needle as well as reducing the risk of injuring persons.

SUMMARY

In the present application, when the term “distal” is used, this refersto the direction pointing away from the dose delivery site. When theterm “distal part/end” is used, this refers to the part/end of thedelivery device, or the parts/ends of the members thereof, which is/arelocated furthest away from the dose delivery site. Correspondingly, whenthe term “proximal” is used, this refers to the direction pointing tothe dose delivery site. When the term “proximal part/end” is used, thisrefers to the part/end of the delivery device, or the parts/ends of themembers thereof, which is/are located closest to the dose delivery site.

According to a main aspect of the invention, it is characterised by thefeatures of the independent patent claim 1. Preferable embodiments ofthe present invention form the subject of the dependent patent claims.

The present invention relates to a medicament delivery device.Preferably the medicament deliver device may comprise a housing with atleast one housing part, which is configured to receive a medicamentcontainer.

The medicament container is provided with a delivery member, eitherintegral with the medicament container, or arranged as an attachablemember. The medicament delivery member is further preferably arrangedwith a shield that covers said delivery member. In this respect it is tobe understood that a number of different medicament delivery membershields are incorporated in the present invention, such as Rigid NeedleShields (RNS), Flexible Needle Shields (FNS) and combinations of theseare just a few of the feasible shields.

The housing may comprise first connecting means, wherein the devicefurther may comprise a protective cap assembly comprising a protectivecap, which cap may comprise second connecting means. The first and thesecond connecting means are configured such that a displacement of theprotective cap relative to the housing allows the protective cap to beremoved from the housing. In this respect it is to be understood thatthe displacement of the protective cap relative the housing may be alinear displacement, a rotational displacement as well as combinationsof these.

Further, the first and second connecting means may be configured toachieve a positive connection. That is, the two connecting means aredesigned to lock with each other by the form of the connecting means.For example they may be configured as a bayonet connection or a threadedconnection.

As an alternative, the first and second connecting means may beconfigured to achieve a non-positive connection. That is, the twoconnecting means are designed to lock with each other by frictionbetween them.

Further, according to the present invention, the protective cap furthercomprises third connecting means for connecting to the shield of themedicament container such that removal of the protective cap from thehousing causes removal of the shield from the medicament container.

According to one major feature of the invention, the protective capassembly may further comprise first disconnecting means configured tointeract with corresponding second disconnecting means of the housingand of the protective cap such that activation of the disconnectingmeans of the protective cap assembly causes the displacement of theprotective cap relative to the housing. Again, it is to be understoodthat the displacement of the protective cap relative the housing may bea linear displacement, a rotational displacement as well as combinationsof these.

According to one positive alternative of the present invention, theprotective cap assembly may comprise an energy accumulating member. Thisenergy accumulating member may be in the form of a mechanical springmember made of a number of materials that display the appropriatefeatures. If a coiled spring is utilized, it may be a compressionspring, a torsion spring, a flat clock spring, just to mention a few.Other feasible energy accumulating members may include plate springs,gas springs, resilient materials, and the like.

In order to handle the energy accumulating member, it is an advantage ifthe protective cap assembly also comprises an actuating mechanismconfigured to hold said energy accumulating member in an energizedstate, and configured, upon activation, to release said energyaccumulating member for activation of said disconnecting means. With theactuating mechanism, it is for example possible to assemble theprotective cap assembly before it is mounted onto the medicamentdelivery device.

The disconnecting means may comprises a number of different designs,where one possible design is to utilize a nut operably connected to saidhousing and to said protective cap and drivably connected to said energyaccumulating member such that activation of said actuating mechanismcauses said nut to displace said protective cap. If a nut is included inthe protective cap assembly, it is an advantage if the energyaccumulating member is capable of providing a rotating displacement aswell as a displacement in the proximal direction. In this case, atorsion spring or a flat clock spring may be advantageous.

The mechanical connection between the nut and the housing said nut mayhave different designs. For example the nut may be arranged with threadsarranged to cooperate with corresponding threads on said housing.According to another design, the nut may be arranged with a bayonetconnection member arranged to cooperate with corresponding bayonetconnection member on said housing.

According to another major aspect of the present invention, theprotective cap assembly may comprise an actuator operatively connectedto said housing and drivably connected to said energy accumulatingmember, and wherein said actuating mechanism is capable of holding saidenergy accumulating member by said actuator, such that release of saidactuator causes activation of said disconnecting means.

With this design, the energy accumulating member may preferably comprisea compression spring operably arranged between said protective cap andsaid activator, thereby providing a linearly directed force in theproximal direction of the device.

In combination with the energy accumulating member, the actuatingmechanism may comprise a button operably arranged on said protectivecap. A button is easily managed by a user when positioned on the featurethat is to be removed from the medicament delivery device before use.

The advantage with the above design is that the user does not require alot of force or power in order to remove the protective cap. Once theenergy accumulating member has been activated, the protective cap willautomatically be removed from the device, after which the medicamentdelivery device is ready for medicament delivery. Further, because ofthe automatic function of removing the protective cap, the medicamentdelivery device can be designed such that the user does not need tochange grip after removal.

According to a further major aspect of the invention, the disconnectingmeans my as an alternative or variant comprise a mechanical actuatorarranged manually operable, such that a force applied on said actuatorcauses displacement of the protective cap relative to the housing. Withthis feature, the force of displacing the protective cap is obtained byother means than an energy accumulating means, whereby the force may beprovided by a user holding the device with one grip.

For example the mechanical actuator is arranged to be operable by aforce applied in the distal direction of the device. This means that themedicament delivery device may be pressed against a surface with itsproximal end, which will provide a force in the distal direction.Further in this respect, the grip that the user is using for pressingthe device against a surface for removing the protective cap, may wellbe the same grip used for the subsequent medicament delivery steps.

In order to further facilitate the removal of the protective cap, saiddisconnecting means may further comprise transmission means capable oftransmitting a distally directed displacement of said mechanicalactuator to a proximally directed displacement of said protective cap.

The transmission means may for example comprises a rotator operablyconnected to said mechanical actuator to rotate said rotator. In thisrespect it may be advantageous when the rotator is arranged with camsurfaces and protrusions and that said transmission means furthercomprises a guide member arranged with cam surfaces such that rotationof said rotator by said actuator causes a displacement of said rotatorin the proximal direction of the device. The use of a rotator ispositive in the sense that it is capable of providing several featuresand functions in one component. Nevertheless, the transmission means mayinstead comprise a leverage mechanism or other mechanical functions.

A further advantage with the use of a transmission means is that it maybe designed to provide a protective cap displacement force that islarger than the actuator displacement force. Therefore, a user may notneed to use so much force when pressing the device against a surface,which is an advantage for weak users or users with impaired functions ofthe hands.

According to a favourable embodiment of the present invention, theconnecting means is a FNS/RNS remover, and in this respect the removeris operably arranged to said protective cap such that displacement ofsaid protective cap causes an axial displacement of said remover andshield in relation to said medicament container.

In all a very versatile, user-friendly as well as safety-increasingdevice is obtained with the present invention.

These and other aspects of, and advantages with, the present inventionwill become apparent from the following detailed description of theinvention and from the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

In the following detailed description of the invention, reference willbe made to the accompanying drawings, of which

FIG. 1 is a cross-sectional view of a first embodiment of the presentinvention,

FIG. 2 is an exploded view of the embodiment of FIG. 1,

FIGS. 3-6 are detailed views of components comprised in the embodimentof FIG. 1,

FIG. 7 is a cross-sectional view of a second embodiment of the presentinvention,

FIG. 8 is an exploded view of the embodiment of FIG. 7,

FIGS. 9-11 are detailed views of components comprised in the embodimentof FIG. 7,

FIG. 12 is a perspective view of a third embodiment of the presentinvention,

FIG. 13 is an exploded view of the embodiment of FIG. 12,

FIGS. 14-15 are detailed views of components comprised in the embodimentof FIG. 12,

FIGS. 16-17 are detailed views of the function of the embodiment of FIG.12,

FIG. 18 is a perspective view of a fourth embodiment of the presentinvention,

FIG. 19 is an exploded view of the embodiment of FIG. 18,

FIG. 20 is a perspective view of the embodiment of FIG. 18 with aprotective cap removed,

FIG. 21 is a detailed exploded view of a cap assembly of the embodimentof FIG. 18,

FIGS. 22-23 are cross-sectional views of the function of the embodimentof FIG. 18,

FIG. 24 is a perspective view of a fifth embodiment of the presentinvention,

FIG. 25 is an exploded view of the embodiment of FIG. 24,

FIGS. 26-27 are detailed views of components comprised in the embodimentof FIG. 24,

FIG. 28 is a cross-sectional view of the embodiment of FIG. 24,

FIGS. 29-30 are detailed views of components comprised in the embodimentof FIG. 24, and

FIGS. 31-35 are different detailed views of functional states of theembodiment of FIG. 24.

DETAILED DESCRIPTION

A first embodiment of the present invention is shown in the drawings 1to 6. It comprises a proximal part, in the following named front shell10. The front shell 10 is a part of a major housing where the rest ofthe housing has been removed for clarity. Other components and functionscomprised in the device not part of the present invention have also beenremoved for clarity.

The front shell 10 is arranged with a proximally directed neck portion12, FIG. 2, which neck portion 12 is arranged with threads 14 on itsouter surface, which threads 14 form second disconnecting means of thehousing. The front shell 10 is further arranged to accommodate amedicament container 16 in the form of an elongated cylindrical bodywith a collar 18 at its distal end. The inner space of the medicamentcontainer is filled with a medicament where its distal opening is closedby a movable stopper (not shown).

The proximal end of the medicament container 16 is arranged with amedicament delivery member, in the embodiment shown an injection needle20. For protection, the injection needle is surrounded by a needleshield 22, FIG. 2, in the embodiment a so called RNS, rigid needleshield, which comprises an inner tubular sheath of elastic material,such as rubber, enclosing the injection needle. The RNS furthercomprises an outer shell of rigid material, which is enclosing and isattached to the sheath. The medicament container 16 with its RNS 22 ispositioned in the front shell 10 such that the RNS 22 protrudes throughthe threaded proximal neck 12 of the front shell 10.

The device according to the present invention comprises a protective capassembly 24, FIG. 2, that in the embodiment disclosed comprises aprotective cap 26 having a distally directed opening 27, which formssecond connecting means of the device. The protective cap and the frontshell are designed such that the distal end of the protective cap 24with its opening 27 can fit onto a recessed portion 28 of the frontshell 10, which recessed portion 28 forms first connecting means of thedevice, with a certain friction between the two in a longitudinaldirection 30 of the device, whereby the protective cap 26 and the frontshell 10 are designed such that a rotational lock is obtained betweenthe two.

The protective cap assembly 24 further comprises an actuating mechanismincluding an activation member 32, in the embodiment shown in the formof a button 32, FIG. 6, which is slidably arranged on the outer surfaceof the protective cap 26. A portion of the button 32 extends into theprotective cap via an opening, which portion of the button 32 isarranged with a plate-shaped actuation member 34, comprised in theactuating mechanism, and extending in the distal direction.

Further, the protective cap assembly comprises a nut 36, hereafter nameddrive nut, which is arranged with threads 38, FIG. 5, on its innercylindrical surface, forming a first disconnecting means. The threads 38are designed to cooperate with the threads 14 of the neck portion 12 ofthe front shell 10. A proximally directed end surface of the drive nut36 is arranged with a number of proximally directed protrusions 40, FIG.6. These protrusions 40 are arranged to fit into a circumferentiallyextending cut-out 42 on an inner surface of a ring-shaped drive member44, FIG. 5, which drive member 44 is comprised in the firstdisconnecting means. The circumferential cut-out 42 is arranged with anumber of distally directed ledges 46, FIG. 5, such that the protrusions40 of the drive nut 36 engage the ledges 46, causing a rotational lockbetween the drive nut 36 and the drive member 44.

The outer surface of the drive member 44 is further arranged with aledge 48, FIG. 6, which ledge 48 is designed to cooperate with theactuation member 34 such that a rotational lock is obtained of the drivemember 44 when the actuation member 34 is in a position in engagementwith the ledge 48 of the drive member 44. The drive member 44 is furtherarranged with an attachment point 50, FIG. 6, for a drive spring 52,also comprised in the first disconnecting means. In the embodiment shownthe drive spring 52 is a torsion spring having a distal end 54, FIG. 5,which fits in a hole of the attachment point 50 of the drive member 44.The drive member 44 is arranged with a circumferential ledge 56 on itsouter surface, which ledge is arranged to fit into seats 58, FIG. 4, onthe inner surface of the protective cap 26, providing a relative lockingin the longitudinal direction but allowing rotation of the drive member44 in relation to the protective cap 26.

A proximal end 60 of the torsion drive spring is arranged to be engaginga ledge 62, FIG. 4, on a distally directed end surface 63, FIG. 4, inthe interior of the protective cap 26, where the end surface 63 formssecond disconnecting means of the protective cap 26. A shield remover 64is further attached to the protective cap, forming a third connectingmeans. The shield remover 64 comprises a cylindrical member providedwith a circumferential outwardly protruding ledge 66, FIG. 2, at itsproximal end. The proximal end in turn fits into a cylindrical seat 68on a distally directed end surface of the protective cap 26, where thecylindrical seat 68 is arranged with a circumferential groove, intowhich the circumferential ledge 66 of the shield remover 64 fits, suchthat the shield remover 64 is locked with the protective cap 26. Theshield remover 64 is further arranged with tongues 68 at its distal end,which tongues 68 are directed in the proximal direction and inclinedwith respect to the longitudinal direction of the device.

The device according to the present invention is intended to be attachedto the front shell 10 such that the drive nut 36 is threaded onto theneck portion 12 of the front shell 10. A medicament container 16 with anRNS 22 is fitted into the front shell 10.

The drive spring 52 is placed into the protective cap with its proximalend 60 in engagement with the ledge 62 and the drive member 44 isattached to the distal end 54 of the drive spring 52. Then the drivemember 44 is pushed into the protective cap and locked into the seats 58of the protective cap 26. The push button 32 is pushed in the proximaldirection, which allows the drive member 44 to be rotated with asuitable tool (not shown) until the drive spring 52 has been tensioned acertain amount. Then the push button 32 is pushed back in the distaldirection whereby the actuation member 34 is moved in engagement withthe protrusion 48 of the drive member 44, thereby rotationally lockingthe drive member 44 with a tensioned drive spring 52.

The protective cap assembly 24 is then pushed onto the front shell 10,whereby the shield remover 64 encloses the rigid shell of the RNS 22.During the movement of the shield remover 64 in relation to the RNS 22,the inclined tongues 68 will come in contact with the rigid shell andflex radially outwards and slide along the outer surface of the rigidshell. When the protective cap 26 has been pushed in position on thefront shell 10, and held there by frictional contact, the proximallydirected protrusions 40 of the drive nut 36 fit into the groove 42 ofthe drive member 44. The device is now ready to be used. This initialposition is shown in FIG. 1.

When a user now intends to administer a dose of medicament, first theprotective cap assembly 24 has to be removed. The user then pushes thebutton 32 of the activation mechanism in the proximal direction. Thiscauses the actuation member 34 to be moved out of contact with the ledge48 of the drive member 44. The drive member 44 is now free to rotate andwill do so due to the force of the torsion spring 52. Due to therotational lock between the drive member 44 and the drive nut 36, thelatter will also rotate along the threads 14 of the front shell 10,whereby the drive nut 36 is moved in the proximal direction. Thismovement in the proximal direction forces the whole protective capassembly 24 in the proximal direction, including the shield remover 64.The inclined tongues 68 of the shield remover 64 will in turn grip intothe rigid shell of the RNS 22, whereby also the RNS 22 will be moved inthe proximal direction. The length of the threaded neck portion 12 andthe strength of the drive spring 52 is designed such that the drive nut36 is rotated until the protective cap 26 is removed from the frontshell 10 as well as the RNS 22 is removed from the injection needle 20of the medicament container 16, whereby the protective cap 26 falls offor is lifted off. The rotation of the drive nut 36 is thus stopped andit merely rests on the neck portion 12 of the front shell 10. The deviceis now ready for penetration and injection of medicament.

It is of course possible to remove the protective cap assembly 24 fromthe medicament delivery device purely manually without activating theautomatic protective cap remover. The user may merely grip theprotective cap and pull it in the proximal direction against thefriction force between the protective cap and the front shell and thefriction between the injection needle and the sheath.

FIGS. 7-12 show a second embodiment of the present invention. Itcomprises a front shell 110 of a medicament delivery device. The frontshell 110 is arranged to accommodate a medicament container 112 havingan injection needle 114 at its proximal end, which injection needle 114is protected by a needle shield 116, in the embodiment shown a RNS. TheRNS 116 is protruding through a proximally directed neck portion 118 ofthe front shell 110. A generally cylindrical actuator 120, forming firstdisconnecting means, is arranged on the neck portion 118 and having adistally directed end surface in contact with a shoulder portion 122 ofthe front shell 110 surrounding the neck portion 118, which shoulderportion 122 forms second disconnecting means of the housing. Theactuator 120 is further arranged with a radially directed shoulder 124.

The actuator 120 is intended to fit into a protective cap 126 comprisedin a protective cap assembly 128 of the invention, FIG. 8, where theshoulder portion 124 of the actuator 120 has a shape corresponding tothe interior shape of the protective cap 126, thereby providing arotational lock of the actuator 120 in relation to the protective cap126. The protective cap 126 is arranged at the proximal end of themedicament delivery device having a distally directed opening 127arranged to be pushed onto a recessed portion 129, forming a firstconnection means, of the front shell 110 and held there by friction,where the opening 127 forms second connecting means. Further acompression spring 130, comprised in the first disconnecting means, isarranged between a distally directed interior surface 131 of theprotective cap 126 and a proximally directed end surface of the actuator124, where the interior surface 131 second disconnecting means of theprotective cap.

The protective cap assembly 128 further comprises an actuating mechanismincluding an activation member on an outer surface of the protectivecap, in the embodiment shown a button 132, FIG. 9, slidable in adirection transversal to the longitudinal direction 134 of the device.The button 132 extends through an opening of the protective cap 126 andis attached to a plate-shaped actuation member 136, comprised in theactuating mechanism. The actuation member is in an initial position incontact with a distally directed surface of the shoulder of theactuator, FIG. 9. The shoulder portion is further arranged with acut-out 138, FIG. 10, adjacent the actuation member 136.

A shield remover 140, FIG. 8, is further attached to the protective cap,which shield remover forms third connecting means. The shield remover140 comprises a cylindrical member provided with a circumferentialoutwardly protruding ledge 142 at its proximal end. The proximal end inturn fits into a cylindrical seat 143, FIG. 7, on a distally directedend surface of the protective cap, where the cylindrical seat isarranged with a circumferential groove (not shown), into which thecircumferential ledge 142 fits, such that the shield remover 140 islocked with the protective cap 126. The shield remover is furtherarranged with tongues 144 at its distal end, which 144 tongues aredirected in the proximal direction and inclined with respect to thelongitudinal direction 134 of the device.

When the protective cap assembly 128 is to be arranged to the device,the compression spring 130 is placed inside the protective cap 126. Thebutton 132 is then slid from the initial position after which theactuator 124 is pressed into the protective cap against the force of thespring 130, thereby compressing the latter. The button 132 is thenreturned to its initial position, whereby the spring 130 is heldcompressed inside the protective cap 126. The protective cap assembly128 is then pushed onto the recessed portion 129 of the front shell 110,whereby the remover 140 encloses the rigid shell of the RNS 116. Duringthe movement of the remover in relation to the RNS, the inclined tongues144 will come in contact with the rigid shell and flex radially outwardsand slide along the outer surface of the rigid shell. When theprotective cap 126 has been pushed in position on the front shell, andheld there by frictional contact, a distally directed surface of theactuator 120 is in contact with the shoulder portion 122 of the frontshell, as shown in FIG. 7. The device is now ready to be used.

When a user now intends to administer a dose of medicament, first theprotective cap assembly 128 has to be removed. The user then pushes thebutton 132 of the actuating mechanism in the transversal direction. Thiscauses the actuation member 136 to be moved to the recess 138 of theshoulder 124 of the actuator, and thereby out of contact with theactuator 124, whereby the force of the compression spring 130 isreleased such that it presses the actuator 120 in the distal directionagainst the shoulder 122 of the front shell 110. The force of the spring130 causes the protective cap 126 to be moved in the proximal directionagainst the friction forces between the protective cap 126 and the frontshell 110 and the RNS and the injection needle respectively such thatthe protective cap assembly 128 with the needle shield 116 is removed,thereby exposing the injection needle 114. The device is now ready forpenetration and injection of medicament.

It is of course possible to remove the protective cap assembly from themedicament delivery device purely manually without activating theautomatic protective cap remover. The user may merely grip theprotective cap and pull it in the proximal direction against thefriction force between the protective cap and the front shell and thefriction between the injection needle and the sheath.

FIGS. 12 to 17 show a third embodiment of the present invention. In thisembodiment the medicament container with its needle shield as well aswith its shield remover have been omitted, but it may readily beunderstood by the person skilled in the art that the same components andfeatures described above may be applied to the third embodiment withoutdeparting from the inventive idea.

A proximal end of a housing 210 of a medicament delivery device isarranged with a protective cap assembly 212, FIG. 12. The protective capassembly 212 comprises a protective cap 214, FIG. 13, having a distallydirected opening 215, forming second connecting means, and is designedto fit onto a recessed part 216, forming a first connecting means, at aproximal end of the housing and held there by certain friction betweenthe protective cap 214 and the housing 210. The design of the protectivecap 214 and the housing part 216 is such that the protective cap 214 isrotationally locked to the housing 210.

The protective cap assembly 212 further comprises a guide member 218,FIG. 13, of a generally tubular shape, forming a first disconnectingmeans. The guide member 218 is arranged to contact a proximal endsurface 220 of the housing with a distal end surface, which proximal endsurface 220 forms second disconnecting means. The guide member 218 isarranged with longitudinally extending guides 222, FIG. 14, which arearranged to fit in corresponding grooves 224 on inner surfaces of theprotective cap 214. With this arrangement, the guide member 218 isrotationally locked to the protective cap 214 and thereby to the housing210. A proximally directed end surface of the guide member 218 isarranged with a cut-out 226 having an inclined first surface 228, FIG.13.

The protective cap assembly 212 further comprises a rotator 230 having agenerally tubular shape, which rotator 230 is comprised in the firstdisconnecting means. The rotator 230 has a diameter somewhat smallerthan the guide member 218 and arranged extending into the guide member.The rotator 230 is arranged with a radially outwardly extendingprotrusion 232, FIGS. 14 and 15, which protrusion 232 is designed to bein contact with the first inclined surface 228, as will be explained.The rotator 230 is further arranged with a cut-out 234 having aninclined second surface 236, FIG. 13.

The protective cap assembly 212 further comprises an actuator 238, FIGS.13 and 14, having a general U-shape and arranged extending through anopening 240 in a proximal end surface of the protective cap 214, wherethe opening 240 has a shape corresponding to the shape of the actuator238. The actuator 238 is further arranged with a radially extendingprotrusion 242, FIGS. 14 and 15, on a side surface, which protrusion 242is designed to be in contact with the second inclined surface 236, aswill be explained. The protective cap 214 is further arranged with adistally directed end surface 246, FIG. 14, forming second disconnectingmeans of the protective cap.

The third embodiment is intended to function as follows. When theprotective cap assembly 212 is pushed onto the proximal end of thehousing, it is held in place by friction between the protective cap 214and the housing 210. Further a needle shield, such as an RNS, isextending through a neck portion 244, FIG. 13 of the housing. The needleshield is surrounded by a remover (not shown), forming a thirdconnection means, which in turn is attached to the interior of theprotective cap 214.

When a user is to remove the protective cap assembly for administering adose of medicament, the medicament delivery device is gripped such thatthe proximal part of the device, including the protective cap assembly212, may be pressed against a rigid surface. Thus, when the protectivecap assembly 212 is pressed, the actuator 238 is forced in the distaldirection into the protective cap 214. This linear movement causes theprotrusion 242 of the actuator 238 to act on the second inclined surface236 of the rotator 230, FIG. 16. Due to the inclination of the secondsurface 242 and the rotational lock of the actuator 238, the rotator 230is forced to rotate.

The rotation of the rotator 230 causes its protrusion 232 to act on thefirst inclined surface 228 of the guide member 218. Due to theinclination of the first inclined surface 228 and the rotational lock ofthe guide member 218, the rotator 230 is moved in the proximal directionduring rotation, FIG. 17. The rotator 230 is designed such that aproximal end surface thereof is in contact with the distally directedsurface 246 of the protective cap 214 whereby a movement of the rotator230 in the proximal direction causes also the protective cap 214 to bemoved in the proximal direction against the friction force between theprotective cap and the housing and the friction force between the needleshield and the injection needle.

When the actuator 238 has been pressed fully into the protective cap214, the protective cap 214 has moved such in the proximal directionthat it is out of contact with the housing 210 and may be completelyremoved. In this respect it is to be understood that the protrusions232, 242 on the rotator 230 and the actuator 238 as well as the inclinedsurfaces 228, 236 of the guide member 218 and the rotator 230 are chosensuch that the force requirements are kept moderate and that the strokeof the rotator 230 enables loosening of the protective cap assembly 212.

The third embodiment may also be completely manually removed in that auser may grip the protective cap and pull it in the proximal directionagainst the forces holding it in place, thereby pulling of theprotective cap assembly from the medicament delivery device. Anadvantage with this solution is that the initial grip of the device forremoving the protective cap assembly may be continued during thesubsequent penetration and injection. Thus, a user does not need tochange grips during administration.

FIGS. 18 to 24 disclose a fourth embodiment of the present invention. Itcomprises a housing part 310 provided with a proximal area 312 having areduced size in the general radial direction, providing a proximallydirected ledge 314. Inside the housing part and protruding through theproximal area, a medicament container 316 is arranged to be positioned.A proximal end of the medicament container 316 is arranged with amedicament delivery member 318, FIG. 20, either attached to or madeintegral with the medicament container 316. The medicament deliverymember is covered by a protective needle shield 320, such as e.g. an RNSor an FNS. In the embodiment shown, the shield is a FNS.

A protective cap assembly 322 is further provided to the device. Itcomprises a protective cap 324 having a generally tubular shape with adistally directed opening 326, FIG. 21. The shape and the dimensions ofthe opening 326 is such that it fits onto the proximal area 312 of thehousing with a certain friction, with a distally directed end surface327 in contact with the ledge 314 of the housing 310. An inner, distallydirected, surface 328 of an end wall 330 of the protective cap isarranged with a generally tubular member 332, extending in the distaldirection. On the inner surface of the tubular member 332, a number ofgrip members 334 are arranged, FIG. 21, designed as wedge-shapedprotrusions, the function of which will be explained below.

An actuator member 336, FIG. 21, is arranged to the protective cap 324,in the form of an elongated member arranged slidable and protrudingthrough a passage 338, FIG. 19, in the end wall 330 of the protectivecap. A distal end of the actuator member 336 is attached to, or madeintegral with, a ring-shaped activation member 340, FIG. 21, such thatthe connection between the actuator member 336 and the activation member340 provides some hinge action. On an opposite end of the ring-shapedactivation member 340 in relation to the hinge connection, a generallyradially outwardly directed protrusion 342 is arranged. The protrusionis intended to fit into a recess 344 on an inner side surface of theprotective cap 324, providing a hinge 345, FIG. 22, 23. Further, theproximally directed end surface of the housing is arranged in twosections 346, 348, FIG. 19, inclined with respect to a longitudinaldirection 350 of the device, whereby two pointed projections 352 areobtained.

The device is intended to function as follows. The safety cap assembly322 is arranged such that the ring-shaped activation member 340 isplaced inside the protective cap 324 with its protrusion 342 in therecess 344 and the actuation member 336 extending through the opening ofthe protective cap 324. The protective cap assembly 322 is pushed ontothe proximal, recessed, end 312 of the housing 310, which housing 310contains a medicament container 316 with its medicament delivery member318 covered by a shield 320. When the protective cap 324 is pushed ontothe housing, the tubular member 332 of the protective cap surrounds theshield 320, FIG. 20. The wedge-shaped grip members 334 slide along thesurface of the shield 320 until the distal end surface comes in contactwith the ledge 314, FIG. 22.

When the protective cap 324 is to be removed, the proximal end of thedevice, and thus the protective cap assembly 322, is pressed against afirm surface. This causes the actuation member 336 to be pushed in thedistal direction, FIG. 22, in relation to the protective cap 324. Themovement in the distal direction of the actuation member 336 causes thering-shaped activation member 340 to be also moved in the distaldirection due to the inter-connection between the two. However, due tothat the opposite side of the ring-shaped activation member 340 isattached to the protective cap via the hinge 345 and due to the pointedprojections 350, which are placed generally between the hinge 345 andthe connection of the actuation member 336, the ring-shaped activationmember 340 will pivot around the pointed projections 350, FIG. 23. Inturn, this pivot action causes the hinge 345 to move in the proximaldirection, and thus the protective cap 324 to move in the proximaldirection, whereby the protective cap 324 is pushed off the housing partagainst the friction force between the protective cap and the housingpart 312. Because of the grip members 334 gripping into the shield 320,the shield 320 will also be pushed off the medicament delivery member318. When the protective cap assembly is removed, the device is readyfor medicament delivery.

It is to be understood that the fourth embodiment may also be completelymanually removed in that a user may grip the protective cap and pull itin the proximal direction against the forces holding it in place,thereby pulling of the protective cap assembly from the medicamentdelivery device. An advantage with this solution is also that theinitial grip of the device for removing the protective cap assembly maybe continued during the subsequent penetration and injection. Thus, auser does not need to change grips during administration.

A fifth embodiment of a medicament delivery device comprising aprotective cap assembly 410 according to the present invention is shownin the drawings 24 to 35. It comprises a generally tubular sleeve,hereafter named ejector sleeve 412, FIG. 25. The inner diameter of theejector sleeve 412 is chosen somewhat larger than a proximal end part ofa housing 414 of the medicament delivery device, e.g. a front shell,which proximal end may for example comprise an activation member 416slidable along a longitudinal axis 415 of the device for activating e.g.penetration and injection of the device. The ejector sleeve 412 isarranged with a circumferential outwardly directed ledge 418 at itsdistal end, FIGS. 26 and 27. A distal surface of the ledge 418 isintended to be in contact with a proximally directed circumferentialsurface area 420, FIG. 25 of the medicament delivery device, comprisedin second disconnecting means of the housing. The ejector sleeve 412 isfurther arranged with circumferential inwardly directed ledge 422 at itsproximal end, FIG. 27, forming a circularly shaped passage 424. Theledge 422 is arranged with a number of slits 426, the function of whichwill be described below.

A generally tubular cap 428, FIGS. 26 and 27, is arranged radiallyoutside, and coaxial with, the ejector sleeve 412. The inner diameter ofthe cap 428 is chosen generally the same as the outwardly directeddistal ledge 418 of the ejector sleeve, thereby causing acircumferential gap 430, FIG. 28, between the ejector sleeve 412 and thecap 428. The cap 428 is arranged with inwardly directed protrusions 432comprised in a second connecting means, FIGS. 29 and 31, at its distalend, which protrusions fit into a circumferential groove 434 comprisedin a first connecting means; FIGS. 25 and 31, on a side surface of onthe housing 414 adjacent the proximally directed surface 420 such thatthe cap 428 is releasibly attached to the housing 414 of the medicamentdelivery device. An end wall 436, FIGS. 27 and 29, is further arrangedin the proximal end of the cap 428, comprised in a second disconnectingmeans of the cap.

On an inner surface of the end wall 436, a generally tubular removermember 438, FIG. 29, is attached. The remover member 438 is arrangedextending into the passage of the ejector sleeve 412. An inner surfaceof the tubular remover member 438 is arranged with a circumferentialgroove 440. A circumferential protrusion 442 arranged on an outersurface of a tubularly shaped needle shield remover 444 comprised in athird connecting means, FIG. 29, fits into the circumferential groove440, thereby locking the needle shield remover 444 to the remover member438. The needle shield remover 444 is further arranged with an inwardlyinclined, proximally directed gripping member 445, which gripping memberis intended to grip into the elastic material of a flexible needleshield 446, which needle shield 446 surrounds an injection needle 448 aswell as a proximal neck portion 450 of a medicament container 452, FIG.28. The remover member 438 is further arranged with a circumferential,outwardly extending ledge 439 at a distal end thereof, FIG. 29.

An activation member 454, FIG. 25, is arranged in the proximal end ofthe device. It comprises a generally disc-shaped contact member 456,FIG. 27, having a proximally directed contact surface. From the distalsurface of the contact member 456, two arms 458, FIGS. 26 and 27, extenddistally. The arms 458 have generally rectangular shape as seen in across-section. Each arm extends into passages 460, FIG. 26, formed inthe end wall 436 of the cap 428, where the shape of the passages 460generally correspond to the rectangular cross-sectional shape of thearms 458. The arms 458 further extend into the gap 430 between theejector sleeve 412 and the cap 428. The activation member 454 isconnected to an energy accumulating member 462, e.g. a spring, FIG. 25.Together they form a first disconnecting means. The spring is arrangedbetween the outwardly extending ledge 418 of the ejector sleeve 412 anda distally directed end surface of the arms 458, urging the activationmember 454 in the proximal direction. In an initial position, theactivation member 454 is however locked from being moved in the proximaldirection by a first set of ledges 464, FIG. 27, extending from sidesurfaces of the arms 458 and being in contact with a distal surface ofthe end wall 436 of the cap 428, FIG. 30.

The arms 458 are also arranged with locking members, e.g. a second setof ledges 466, extending from side surfaces of the arms 458. The ledgesare generally wedge-shaped as seen in the figures, the function of whichwill be described below. The arms 458 are further arranged with cut-outs468 positioned between each set of second ledges 466, as will also bedescribed.

The device is intended to function as follows. It is intended to beattached to the housing 414 of a medicament delivery device with theinwardly extending protrusions 432 of the cap 428 fitting into thecircumferential groove 434 of the housing 414. A medicament container452 with an FNS 446 is fitted into the housing 414, FIG. 28. When thedevice is attached to the housing 414, the needle shield of the FNS 446slides into the needle shield remover 444. In the initial position, asseen in FIG. 28, the activation member 454 extends from the cap 428 inthe proximal direction, biased by the spring 462. The distal surface ofthe end wall 436 of the cap 428 is in contact with a proximal endsurface of the ejector sleeve 412.

When the cap assembly is to be removed in order to use the medicamentdelivery device the user presses the activation member 454 at theproximal end of the device against a surface. The contact member 456with the arms 458 will then be moved in the distal direction against theforce of the spring 462. The arms 458 will move into the cap 428 and thesecond set of ledges 466 will pass the passages 460 of the cap. Thepassing of the second set of ledges 466 is facilitated by thewedge-shape of the ledges and the cut-outs 468 in the arms, where thelatter enable a flexing transversal movement of the ledges 466. When theledges 466 have passed the passages 460, the contact member 456 islocked from movement in the proximal direction relative to the cap 428because the ledges 466 are locked by the distal surface of the end wall436 of the cap 428, as seen in FIG. 32. The spring 462 has in turn beencompressed by the movement of the contact member in the distaldirection, building up a force in the spring 462, FIG. 31.

This force is now sufficient to overcome the holding forces between theprotrusions 432 of the cap 428 and the groove 434 of the housing 414,whereby the cap 428 is moved in the proximal direction together with thecontact member 456. The movement of the cap 428 also causes the needleshield remover 444, attached to the cap, to move in the proximaldirection relative to the housing 414. The inclined gripping member 445of the shield remover 444 will in turn grip into the flexible materialof the FNS 446, whereby also the FNS 446 will be moved in the proximaldirection, FIG. 33, relative to the injection needle 448. When the cap428 has moved in the proximal direction a certain length, at a positionwhere the FNS 446 is out of contact with the injection needle 448 andthe proximal end of the medicament container, FIG. 34, thecircumferential outwardly extending ledge 439 of the remover member 438,will come in contact with the inwardly directed ledge 422 of the ejectorsleeve 412. Thus, the whole assembly is now removed, FIG. 35, and themedicament delivery device is ready for injection.

It is of course possible to remove the protective cap assembly 410according to the fifth embodiment from the medicament delivery devicepurely manually without activating the automatic protective cap remover.The user may merely grip the protective cap and pull it in the proximaldirection against the holding force between the protective cap and thehousing and the friction between the injection needle and the shield.

It is to be understood that the embodiment described above and shown inthe drawings is to be regarded only as a non-limiting example of theinvention and that it may be modified in many ways within the scope ofthe patent claims.

1-31. (canceled)
 32. A medicament delivery device comprising a housingconfigured to receive a medicament container having a delivery memberand a shield that covers said delivery member, the housing having alongitudinal axis, where the housing comprises a proximal end having afirst connector; a protective cap comprising a second connectorconfigured to engage the first connector to secure the protective cap tothe housing, wherein the first and the second connectors are configuredsuch that an axial displacement of the protective cap relative to thehousing disconnects the first and second connectors, and wherein theprotective cap further comprises a third connector connecting the shieldto the protective cap such that removal of the protective cap from thehousing causes removal of the shield from the medicament container, anactuator operably associated with the protective cap; and adisconnection member operably connected to both the actuator and theprotective cap wherein movement of the actuator causes the disconnectionmember to exert an axial force on the protective cap to cause theprotective cap and the shield to move in a proximal directiondisconnecting the first connector from the second connector.
 33. Thedevice of claim 32, further characterized in that connecting the firstconnector to the second connector forms a releasable friction fit suchthat a non-rotating axial movement of the protective cap relative to theproximal end of the housing causes disconnection of the friction fit.34. The device of claim 32, where the third connector comprises apositive connection.
 35. The device of claim 34, where the positiveconnection locks a shield remover to the protective cap such that axialmovement of the protective cap in the proximal direction causes axialmovement of the shield remover to cause removal of the shield from thedelivery member
 36. The device of claim 32, where the disconnectionmember comprises a biasing member.
 37. The device of claim 36, where thebiasing member comprises a spring.
 38. The device of claim 32, where thedisconnection member comprises a rotator.
 39. The device of claim 32,where the disconnection member comprises a hinged activator.
 40. Thedevice of claim 32, where the actuator is a button configured to sliderelative to the protective cap.
 41. The device of claim 32, where theactuator protrudes outwardly from an opening in a proximal face of theprotective cap and is configured slide axially in a distal directionrelative to the protective cap.
 42. The device of claim 41, where thesliding axial movement of the actuator causes the disconnection memberto disconnect the first connector from the second connector.
 43. Thedevice of claim 37, where a first end of the spring is biased againstthe protective cap and a second end of the spring is held in acompressed state by the actuator.
 44. The device of claim 43, where thesecond end of the spring is connected to a drive member, whereengagement of the drive member and the actuator axially and rotationallyfixes the drive member relative to the housing and where disengagementof the actuator from the drive member causes the drive member to moveproximally relative to the housing.
 45. The device of claim 39, wherethe proximal end of the housing provides a pivot point operativelyconnected to the hinged activator.
 46. The device of claim 38, where therotator comprises at least one inclined surface and at least oneprotrusion where one of the inclined surface or protrusion operativelyengages a guide member to effect rotation of the rotator.
 47. The deviceof claim 46, where rotation of rotator disconnects the first connectorfrom the second connector.
 48. The device of claim 32, where thedisconnection member is configured to provide a protective capdisplacement force that is larger than the axial force required to movethe actuator.
 49. The device of claim 32, where user applied manualmovement of the actuator causes automatic movement of the disconnectionmember that causes automatic axial movement of the protective cap andthe shield in the proximal direction.
 50. The device of claim 32, wherethe shield comprises a FNS, RNS or combination of FNS/RNS.
 51. Thedevice of claim 32, where the delivery member comprises a needle, anozzle or a mouthpiece.